Eko Health is MDSAP certified and ISO 13485:2016 certified.
The following Eko products are FDA cleared, CE marked (Eko CORE 500™ Digital Stethoscope, Eko CORE™, Eko Analysis Software), and UKCA marked. For additional regulatory information or requests for Declaration of Conformity, please see the links below or contact support.
Eko CORE 500™ Digital Stethoscope FDA Clearance Statement K230111
Eko CORE 500™ Digital Stethoscope FDA Clearance Statement K233609
Eko CORE™ FDA Clearance Statement K200776
Eko Analysis Software FDA Clearance Statement K192004
Eko Murmur Analysis Software (EMAS) FDA Clearance Statement K213794
Eko Low Ejection Fraction Tool (ELEFT) FDA Clearance Statement K233409
Eko Health, Inc. is dedicated to maintaining public trust in the integrity of our research-related activities. The management of financial conflicts of interest (FCOI) is crucial for safeguarding research objectivity and for compliance with federal regulations.
Eko Health, Inc. seeks to ensure the integrity of its research and to comply with the Public Health Service (PHS) requirements for institutions that seek research funding. The PHS has implemented regulations (42 CFR 50, “FCOI Regulations”) to promote objectivity in research by establishing standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under PHS grants will be free from bias resulting from investigator FCOIs.
This policy includes any research performed at Eko that is funded from NIH monies (PHS grants).
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Eko may be the primary research institution.
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Eko may be a sub-investigating/contracted research institution.
This policy includes any investigators that are participating in NIH-funded research at Eko or any subcontracting organization. The policy provides mandatory training, policy documentation and essential details on processes that investigators must follow to comply with FOCI Regulations.